- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification, process ... data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and… more
- BioAgilytix (San Diego, CA)
- … systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP guidelinesAdvanced ... IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation ... Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity and… more
- Merck & Co. (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation ... plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP… more
- Twist BioScience (South San Francisco, CA)
- …Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for… more
- Merck & Co. (Rahway, NJ)
- …is responsible for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC ... systems comply with regulatory standards (eg, FDA, cGMP), maintain...have strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… more
- Merck & Co. (Rahway, NJ)
- …performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating ... ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Repligen (Rancho Dominguez, CA)
- …device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO ... Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation , and… more
- Merck & Co. (Durham, NC)
- …PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical ... and assisting process project engineers.Assists with execution of automation, validation and additional testing, as requiredFollows instructions for completion of… more
- Eisai, Inc (Nutley, NJ)
- …software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS ... with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively… more
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Merck & Co. (Rahway, NJ)
- …Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze data, and ... in the purification of biological molecules, including chromatography and filtration systems .Technology Transfer Experience: Proven track record in tech transfer or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
